Paul M Arnold1, Rick C Sasso2, Michael E Janssen3, Michael G Fehlings4, Robert F Heary5, Alexander R Vaccaro6, Branko Kopjar7. 1. Department of Neurosurgery, University of Kansas Medical Center, Kansas City, Kansas. 2. Indiana Spine Group, Carmel, Indiana. 3. Center for Spine & Orthopedics, Thornton, Colorado. 4. Department of Neurosurgery, University of Toronto, The Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada. 5. Department of Neurological Surgery, Neurological Institute of New Jersey, Rutgers New Jersey Medical School, Newark, New Jersey. 6. Rothman Institute Orthopaedics, Thomas Jefferson University Hospital, Philadelphia Pennsylvania. 7. Department of Health Services, University of Washington, Seattle, Washington.
Abstract
BACKGROUND: i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE: To report 2-yr follow-up. METHODS: Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS: At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION: Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.
RCT Entities:
BACKGROUND: i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE: To report 2-yr follow-up. METHODS: Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS: At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION: Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.
Authors: Andrew L Alejo; Scott McDermott; Yusuf Khalil; Hope C Ball; Gabrielle T Robinson; Ernesto Solorzano; Amanda M Alejo; Jacob Douglas; Trinity K Samson; Jesse W Young; Fayez F Safadi Journal: J Orthop Sports Med Date: 2022-09-05
Authors: Paul M Arnold; Alexander R Vaccaro; Rick C Sasso; Benoit Goulet; Michael G Fehlings; Robert F Heary; Michael E Janssen; Branko Kopjar Journal: Global Spine J Date: 2020-04-03
Authors: Patrick C Hsieh; Andrew S Chung; Darrel Brodke; Jong-Beom Park; Andrea C Skelly; Erika D Brodt; Ki Chang; Zorica Buser; Hans Joerg Meisel; S Timothy Yoon; Jeffrey C Wang Journal: Global Spine J Date: 2020-09-23